Clinical trials: Early Phase 1
Osteopenia
Melatonin and Osteogenic Loading on Osteopenia
This study will be assessing the efficacy of melatonin and/or osteogenic loading on modulating bone health in an osteopenic population.
- Trial name
- MelaOstrong (NCT04233112)
- Testing
- Melatonin 5 mg, Osteogenic loading, Mock for Osteogenic Loading
- Where
- 2 sites in United States
- Volunteers
- 27 people
- Sponsor
- Duquesne University
Interaction Drug Food
Assessing the Pharmacokinetics and Drug Interaction Liability of Kratom, an Opioid-like Natural Product
Kratom is a botanical natural product that has opioid-like effects. Kratom is commonly used to self-treat withdrawal symptoms associated with opioid addiction, as well as pain.
- Trial name
- NCT04392011
- Testing
- Midazolam HCl, Dextromethorphan HBr, Kratom
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Washington State University
Endometriosis
Cardiovascular Disease Risk in Women With Endometriosis
To test the hypothesis that estrogen suppression impairs endothelial dysfunction in endometriosis.
- Trial name
- NCT03746535
- Testing
- Elagolix
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Yale University
Mesenchymal Stromal Cells, Cornea
Safety of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
This study is a longitudinal assessment using a classic dose-escalation study design to assess the safety and maximal tolerated dose (MTD) of topical MSC Secretome eye drops.
- Conditions
- Mesenchymal Stromal Cells, Cornea, Corneal Defect, Corneal Epithelium Defect
- Trial name
- MSC Secretome (NCT05204329)
- Testing
- MSC Secretome Eye Drops
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- University of Illinois at Chicago
Carcinoma of the Anal Canal
Concurrent Chemoradiation + 5-FU + Mitomycin-C in Anal Carcinoma
This research study is a Pilot Study. Pilot studies are conducted to see if it is practical to do this type of research ona larger scale in the future.
- Trial name
- NCT01858025
- Testing
- Pencil Beam scanning Radiation, 5-fluorouracil, Mitomycin-C
- Where
- 2 sites in United States
- Volunteers
- 25 people
- Sponsor
- Massachusetts General Hospital
Dengue
Immunogenicity of an Intradermal Qdenga Vaccine Among Healthy Volunteers
Official title: Immunogenicity of an intradermal Qdenga vaccine among healthy volunteers: A pilot study
- Trial name
- NCT06837116
- Testing
- Vaccine
- Where
- 2 sites in Thailand
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Prince of Songkla University
Decompensated Heart Failure
Mechanism and Effects of Manipulating Chloride Homeostasis in Stable Heart Failure
This study is designed to investigate the quantitative effects of sodium-free chloride supplementation on electrolyte balance, volume status, and sodium avidity in stable heart failure patients in a highly controlled environment.
- Trial name
- NCT03440970
- Testing
- Lysine Chloride
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Yale University
Obesity, Childhood
Pharmacokinetics and Pharmacodynamics of Topiramate for Weight Loss in Youth: PHARMATOP
Pediatric severe obesity is the fastest growing obesity category in the United States, and anti-obesity pharmacotherapies are promising adjuncts to lifestyle modification (LSM) for the treatment of this disease.
- Trial name
- PHARMATOP (NCT04986631)
- Testing
- Topiramate Tablets
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- University of Minnesota
Head and Neck Carcinoma of Unknown Primary, Locally Advanced Head and Neck Squamous Cell Carcinoma
Tolinapant and Radiation for Cisplatin-Ineligible, Previously Untreated, Locally Advanced Head and Neck Cancer
This early-phase trial tests the safety and side effects of a tolinapant given together with radiation therapy in treating patients with head and neck cancer for which the patient has not received treatment in the past…
- Conditions
- Head and Neck Carcinoma of Unknown Primary, Locally Advanced Head and Neck Squamous Cell Carcinoma, Locally Advanced Hypopharyngeal Squamous Cell Carcinoma, Locally Advanced Laryngeal Squamous Cell Carcinoma
- Trial name
- NCT05245682
- Testing
- Tolinapant, Radiation Therapy
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Emory University
Thyroid Cancer
RAI Plus Immunotherapy for Recurrent/Metastatic Thyroid Cancers
The purpose of this study is to find out what effects, good and/or bad, a drug called durvalumab combined with Thyrogen-stimulated RAI, has on the patient and thyroid cancer.
- Trial name
- NCT03215095
- Testing
- Durvalumab (Medi4736), Radioiodine (RAI)
- Where
- 7 sites in United States
- Volunteers
- 11 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Neurogenic Orthostatic Hypotension, Autonomic Failure
Effect of Midodrine vs Abdominal Compression on Cardiovascular Risk Markers in Autonomic Failure Patients
The purpose of this study is to learn more about the effects of abdominal compression and the medication midodrine, two interventions used for the treatment of orthostatic hypotension (low blood pressure on standing), on…
- Conditions
- Neurogenic Orthostatic Hypotension, Autonomic Failure, Pure Autonomic Failure, Multiple System Atrophy
- Trial name
- NCT04620382
- Testing
- Midodrine, Abdominal compression
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Vanderbilt University Medical Center
Malaria, Plasmodium Falciparum
A Study of the Plasmodium Falciparum Malaria Vaccine Candidate Pfs48/45 in Matrix-M Adjuvant in the UK
This is an open label, single-site, first-in-human, dose-escalation Phase Ia study to assess safety and immunogenicity of the Plasmodium falciparum malaria vaccine candidate Pfs48/45 in Matrix-M adjuvant in healthy adults living…
- Trial name
- NCT05400746
- Testing
- Pfs48/45 in Matrix-M
- Where
- United Kingdom
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Heart Failure
Mechanism and Effects of Manipulating Chloride Homeostasis in Acute Heart Failure
The purpose of this study is to understand the effects of chloride supplementation on volume-overloaded acute heart failure patients concomitantly treated with IV diuretics.
- Trial name
- NCT03446651
- Testing
- Lysine Chloride
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Yale University
Obesity, Childhood, Behavior, Health
Summer Youth Employment Programs for Health Promotion
The purpose of this proof-of-concept study is to assess the initial signal of effectiveness of summer youth employment programs (SYEP) on understudied obesity-related outcomes in adolescents.
- Conditions
- Obesity, Childhood, Behavior, Health, Healthy Lifestyle
- Trial name
- NCT07227220
- Testing
- Summer Youth Employment Program
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- University of Houston
PTSD, Trauma
Neuroendocrine Risk for PTSD in Women
This study will test for effects of estradiol (E2) on PTSD symptoms and functional magnetic resonance imaging (fMRI) indicators of stress vulnerability, in naturally-cycling women who are not using hormonal birth control.
- Trial name
- NCT03973229
- Testing
- Estradiol patch
- Where
- United States
- Volunteers
- 127 people
- Sponsor
- Emory University
Critically Ill Patients
Esketamine Induction Intubation in ICU Patients.
Intubation in the intensive care unit (ICU) is usually an emergency. Pathophysiological changes such as shock, respiratory failure, and metabolic acidosis in critically ill patients can significantly increase the incidence of…
- Trial name
- NCT05464979
- Testing
- Esketamine Hydrochloride 28 Mg in 0.2 mL NASAL SOLUTION [Spravato], midazolam, fentanyl
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Smoldering Plasma Cell Myeloma
Pembrolizumab in Treating Patients With Intermediate or High-Risk Smoldering Multiple Myeloma
This pilot early phase I trial studies pembrolizumab in treating patients with slow growing (smoldering) multiple myeloma with intermediate or high-risk of spreading.
- Trial name
- NCT02603887
- Testing
- Laboratory Biomarker Analysis, Pembrolizumab
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- M.D. Anderson Cancer Center
Pathologic Stage IIA-IIIC Triple-Negative Breast Cancer, TNBC - Triple-Negative Breast Cancer
Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Triple-Negative Breast Cancer
The purpose of this study is to determine the safety as well as the most effective dose of the alpha-lactalbumin vaccine (aLA breast cancer vaccine) to treat patients with non-metastatic triple negative breast cancer…
- Conditions
- Pathologic Stage IIA-IIIC Triple-Negative Breast Cancer, TNBC - Triple-Negative Breast Cancer, Residual Disease
- Trial name
- NCT04674306
- Testing
- α-lactalbumin vaccine, Zymosan
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- George T. Budd
Delta-9-tetrahydrocannabinol (THC), Stress
Effects of Drugs on Stress Memories
There is evidence that cannabinoids, including delta-9-tetrahydrocannabinol (THC), reduce responses to acute stress and fear-related stimuli, but few studies have examined the effects of THC on memories of stressful experiences.
- Trial name
- ETS (NCT06471647)
- Testing
- delta-9-tetrahydrocannabinol (THC) (5), delta-9-tetrahydrocannabinol (THC) (10)
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- University of Chicago
Stage IV Non-small Cell Lung Cancer, Cachexia
Ruxolitinib for Cancer Cachexia
To assess toxicity with use of Ruxolitinib in NSCLC cachexia patients; to associate levels of JAK/STAT signaling in blood, adipose, and muscle pre- and post-ruxolitinib treatment with changes in cachexia and anorexia.
- Trial name
- NCT04906746
- Testing
- Identify any dose-limiting toxicity (DLT) when ruxolitinib is administered to NSCLC cachexia patients.
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Tu Dan